0 Ratings

ID

16100

Description

Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02315495

Link

https://clinicaltrials.gov/show/NCT02315495

Keywords

  1. 6/29/16 6/29/16 -
Uploaded on

June 29, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Type 2 Diabetes NCT02315495

    Eligibility Type 2 Diabetes NCT02315495

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    type 2 diabetes (world health organisation (who) criteria), managed by diet alone (i.e. no oral hypoglycaemic drugs or insulin)
    Description

    Diabetes Mellitus, Non-Insulin-Dependent Diabetic on diet only | Oral hypoglycemic Absent | Insulin Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011860
    UMLS CUI [1,2]
    C0421246
    UMLS CUI [2,1]
    C0359086
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [3,1]
    C0021641
    UMLS CUI [3,2]
    C0332197
    body mass index (bmi) 20 - 40 kg/m2
    Description

    Body mass index

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    age 18 - 70 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    males and post-menopausal females (to control for the effect of the menstrual cycle on gut hormone secretion)
    Description

    Gender | Postmenopausal state | control Menstrual cycle Effect Gut Hormone secretion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0232970
    UMLS CUI [3,1]
    C0243148
    UMLS CUI [3,2]
    C0025329
    UMLS CUI [3,3]
    C1280500
    UMLS CUI [3,4]
    C0699819
    UMLS CUI [3,5]
    C0312431
    glycated haemoglobin a1c (hba1c) ≥ 6.0% and ≤ 7.9%
    Description

    Hemoglobin A1c measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0474680
    haemoglobin above the lower limit of the normal range (i.e. >135g/l for men and 115g/l for women), and ferritin above the lower limit of normal (i.e. >10mcg/l)
    Description

    Hemoglobin measurement | Gender | Ferritin measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0518015
    UMLS CUI [2]
    C0079399
    UMLS CUI [3]
    C0373607
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    use of any medication that may influence gastrointestinal motor function, body weight or appetite
    Description

    Pharmaceutical Preparations Affecting function gastrointestinal motor | Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting appetite

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0031843
    UMLS CUI [1,4]
    C0521362
    UMLS CUI [1,5]
    C1513492
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C0005910
    UMLS CUI [3,1]
    C0013227
    UMLS CUI [3,2]
    C0392760
    UMLS CUI [3,3]
    C0003618
    evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
    Description

    Drug abuse | Alcohol consumption Unit per Gram per Day | Cigarette smoker Number of cigarettes per day

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013146
    UMLS CUI [2,1]
    C0001948
    UMLS CUI [2,2]
    C2349072
    UMLS CUI [3,1]
    C0337667
    UMLS CUI [3,2]
    C3694146
    history of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
    Description

    Gastrointestinal Diseases | Symptoms Significant Upper Gastrointestinal Tract | Symptoms Significant Lower Gastrointestinal Tract | Pancreatitis | Gastrointestinal Surgical Procedure | Appendectomy Uncomplicated | Cholecystectomy Uncomplicated

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0017178
    UMLS CUI [2,1]
    C1457887
    UMLS CUI [2,2]
    C0750502
    UMLS CUI [2,3]
    C3203348
    UMLS CUI [3,1]
    C1457887
    UMLS CUI [3,2]
    C0750502
    UMLS CUI [3,3]
    C0226875
    UMLS CUI [4]
    C0030305
    UMLS CUI [5]
    C0524722
    UMLS CUI [6,1]
    C0003611
    UMLS CUI [6,2]
    C0443334
    UMLS CUI [7,1]
    C0008320
    UMLS CUI [7,2]
    C0443334
    other significant illness, including epilepsy, cardiovascular or respiratory disease
    Description

    Illness Significant | Epilepsy | Cardiovascular Diseases | Respiration Disorders

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423
    UMLS CUI [1,2]
    C0750502
    UMLS CUI [2]
    C0014544
    UMLS CUI [3]
    C0007222
    UMLS CUI [4]
    C0035204
    autonomic nerve damage (as assessed by standardised cardiovascular reflex tests [36])
    Description

    Autonomic nerve injury

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0560614
    impaired renal or liver function (as assessed by calculated creatinine clearance < 90 ml/min or abnormal liver function tests (> 2 times upper limit of normal range))
    Description

    Renal Insufficiency | Liver Dysfunction | Creatinine clearance measurement | Liver function tests abnormal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    UMLS CUI [2]
    C0086565
    UMLS CUI [3]
    C0373595
    UMLS CUI [4]
    C0151766
    allergy to vildagliptin or any other 'gliptin'
    Description

    Hypersensitivity vildagliptin

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1570906
    donation of blood within the previous 3 months
    Description

    Blood Donation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005794
    participation in any other research studies within the previous 3 months
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    females who are pre-menopausal
    Description

    Premenopause

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206158
    inability to give informed consent
    Description

    Informed Consent Unable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C1299582
    vegetarians
    Description

    Vegetarian

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0042441

    Similar models

    Eligibility Type 2 Diabetes NCT02315495

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diabetes Mellitus, Non-Insulin-Dependent Diabetic on diet only | Oral hypoglycemic Absent | Insulin Absent
    Item
    type 2 diabetes (world health organisation (who) criteria), managed by diet alone (i.e. no oral hypoglycaemic drugs or insulin)
    boolean
    C0011860 (UMLS CUI [1,1])
    C0421246 (UMLS CUI [1,2])
    C0359086 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C0021641 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    Body mass index
    Item
    body mass index (bmi) 20 - 40 kg/m2
    boolean
    C1305855 (UMLS CUI [1])
    Age
    Item
    age 18 - 70 years
    boolean
    C0001779 (UMLS CUI [1])
    Gender | Postmenopausal state | control Menstrual cycle Effect Gut Hormone secretion
    Item
    males and post-menopausal females (to control for the effect of the menstrual cycle on gut hormone secretion)
    boolean
    C0079399 (UMLS CUI [1])
    C0232970 (UMLS CUI [2])
    C0243148 (UMLS CUI [3,1])
    C0025329 (UMLS CUI [3,2])
    C1280500 (UMLS CUI [3,3])
    C0699819 (UMLS CUI [3,4])
    C0312431 (UMLS CUI [3,5])
    Hemoglobin A1c measurement
    Item
    glycated haemoglobin a1c (hba1c) ≥ 6.0% and ≤ 7.9%
    boolean
    C0474680 (UMLS CUI [1])
    Hemoglobin measurement | Gender | Ferritin measurement
    Item
    haemoglobin above the lower limit of the normal range (i.e. >135g/l for men and 115g/l for women), and ferritin above the lower limit of normal (i.e. >10mcg/l)
    boolean
    C0518015 (UMLS CUI [1])
    C0079399 (UMLS CUI [2])
    C0373607 (UMLS CUI [3])
    Item Group
    C0680251 (UMLS CUI)
    Pharmaceutical Preparations Affecting function gastrointestinal motor | Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting appetite
    Item
    use of any medication that may influence gastrointestinal motor function, body weight or appetite
    boolean
    C0013227 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0031843 (UMLS CUI [1,3])
    C0521362 (UMLS CUI [1,4])
    C1513492 (UMLS CUI [1,5])
    C0013227 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0005910 (UMLS CUI [2,3])
    C0013227 (UMLS CUI [3,1])
    C0392760 (UMLS CUI [3,2])
    C0003618 (UMLS CUI [3,3])
    Drug abuse | Alcohol consumption Unit per Gram per Day | Cigarette smoker Number of cigarettes per day
    Item
    evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
    boolean
    C0013146 (UMLS CUI [1])
    C0001948 (UMLS CUI [2,1])
    C2349072 (UMLS CUI [2,2])
    C0337667 (UMLS CUI [3,1])
    C3694146 (UMLS CUI [3,2])
    Gastrointestinal Diseases | Symptoms Significant Upper Gastrointestinal Tract | Symptoms Significant Lower Gastrointestinal Tract | Pancreatitis | Gastrointestinal Surgical Procedure | Appendectomy Uncomplicated | Cholecystectomy Uncomplicated
    Item
    history of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
    boolean
    C0017178 (UMLS CUI [1])
    C1457887 (UMLS CUI [2,1])
    C0750502 (UMLS CUI [2,2])
    C3203348 (UMLS CUI [2,3])
    C1457887 (UMLS CUI [3,1])
    C0750502 (UMLS CUI [3,2])
    C0226875 (UMLS CUI [3,3])
    C0030305 (UMLS CUI [4])
    C0524722 (UMLS CUI [5])
    C0003611 (UMLS CUI [6,1])
    C0443334 (UMLS CUI [6,2])
    C0008320 (UMLS CUI [7,1])
    C0443334 (UMLS CUI [7,2])
    Illness Significant | Epilepsy | Cardiovascular Diseases | Respiration Disorders
    Item
    other significant illness, including epilepsy, cardiovascular or respiratory disease
    boolean
    C0221423 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    C0014544 (UMLS CUI [2])
    C0007222 (UMLS CUI [3])
    C0035204 (UMLS CUI [4])
    Autonomic nerve injury
    Item
    autonomic nerve damage (as assessed by standardised cardiovascular reflex tests [36])
    boolean
    C0560614 (UMLS CUI [1])
    Renal Insufficiency | Liver Dysfunction | Creatinine clearance measurement | Liver function tests abnormal
    Item
    impaired renal or liver function (as assessed by calculated creatinine clearance < 90 ml/min or abnormal liver function tests (> 2 times upper limit of normal range))
    boolean
    C1565489 (UMLS CUI [1])
    C0086565 (UMLS CUI [2])
    C0373595 (UMLS CUI [3])
    C0151766 (UMLS CUI [4])
    Hypersensitivity vildagliptin
    Item
    allergy to vildagliptin or any other 'gliptin'
    boolean
    C0020517 (UMLS CUI [1,1])
    C1570906 (UMLS CUI [1,2])
    Blood Donation
    Item
    donation of blood within the previous 3 months
    boolean
    C0005794 (UMLS CUI [1])
    Study Subject Participation Status
    Item
    participation in any other research studies within the previous 3 months
    boolean
    C2348568 (UMLS CUI [1])
    Premenopause
    Item
    females who are pre-menopausal
    boolean
    C0206158 (UMLS CUI [1])
    Informed Consent Unable
    Item
    inability to give informed consent
    boolean
    C0021430 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    Vegetarian
    Item
    vegetarians
    boolean
    C0042441 (UMLS CUI [1])

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